CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000— 510(k) K022107

Name: FDA 510(k) clearance K022107
Creator: U.S. Food and Drug Administration
Published: 2002-08-08

Substantially Equivalent

Cardiomedics, Inc.

FDA 510(k) clearance K022107 for CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000, Substantially Equivalent on 2002-08-08. Applicant: Cardiomedics, Inc.. Device class: 2.

Clearance details

Applicant: Cardiomedics, Inc.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2002-06-28
Decision date: 2002-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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